FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
12337–12360 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 30, 2022
AugMENTA Penile Implant
K200073 · MIB
Augmenta, LLC
General & Plastic Surgery · 990d
Cleared Sep 30, 2022
8mm Monopolar Curved Scissors
K210478 · QSM
Iconocare Health
General & Plastic Surgery · 588d
Cleared Sep 30, 2022
Ultrasonic Surgical System
K210567 · LFL
Miconvey Technologies Co., Ltd.
General & Plastic Surgery · 581d
Cleared Sep 30, 2022
QIR Suite
K211611 · QIH
Casis Cardiac Simulation & Imaging...
Radiology · 493d
Cleared Sep 30, 2022
DoubleChek DC-1001
K212316 · KNT
Nasogastric Feeding Solutions, Ltd.
Gastroenterology & Urology · 431d
Cleared Sep 30, 2022
Blood Pressure Monitor(Model:Y30001)
K213023 · DXN
Zhangzhou Easepal Medical Science and...
Cardiovascular · 374d
Cleared Sep 30, 2022
Kerecis Oral
K213904 · NPL
Kerecis
Dental · 290d
Cleared Sep 30, 2022
Mg-PSZ Ceramic Femoral Head
K220336 · LPH
Theken Companies
Orthopedic · 235d
Cleared Sep 30, 2022
EmbedMed
K220366 · DZJ
3D Lifeprints UK , Ltd.
Dental · 234d
Cleared Sep 30, 2022
e-Ortho Shoulder Software v1.1
K220758 · LLZ
FH Industrie
Radiology · 199d
Cleared Sep 30, 2022
Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA...
K221003 · GDW
Covidien
General & Plastic Surgery · 178d
Cleared Sep 30, 2022
OFNat Lubricant (L15)
K221243 · NUC
Suretex Limited
Obstetrics & Gynecology · 151d
Cleared Sep 30, 2022
Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile
K221378 · LZA
Tec Gloves Industry (M) Sdn.Bhd.
General Hospital · 141d
Cleared Sep 30, 2022
Unscented Menstrual Tampon
K222046 · HEB
Suzhou Borage Medical Technology Co.,...
Obstetrics & Gynecology · 81d
Cleared Sep 30, 2022
Safety Lancet
K222090 · FMK
Ningbo Medsun Medical Co., Ltd.
General & Plastic Surgery · 77d
Cleared Sep 30, 2022
Air Compression Leg Massager (Models: S9036C, S9036B and S9036A)
K222206 · IRP
Shenzhen Dongjilian Medical Tech Co.,...
Physical Medicine · 67d
Cleared Sep 30, 2022
Arthrex 3.5 mm Locking Compression Plates
K222244 · HRS
Arthrex, Inc.
Orthopedic · 66d
Cleared Sep 30, 2022
uDR 380i Pro
K222339 · IZL
Shanghai United Imaging Healthcare...
Radiology · 58d
Cleared Sep 30, 2022
Shield System
K222625 · OWB
Radiaction , Ltd.
Radiology · 30d
Cleared Sep 30, 2022
AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization...
K222849 · NVE
Steris
General Hospital · 9d
Cleared Sep 29, 2022
SpineAR SNAP
K213034 · SBF
Surgical Theater, Inc.
Orthopedic · 373d
Cleared Sep 29, 2022
Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad,...
K213126 · JDO
Smith & Nephew, Inc.
Orthopedic · 367d
Cleared Sep 29, 2022
Ghost Spacer System
K213417 · MAX
Life Spine, Inc.
Orthopedic · 344d
Cleared Sep 29, 2022
InnovaBurn
K213716 · KGN
Triad Life Sciences, Inc.
General & Plastic Surgery · 309d